When my mother tells me that her computer is running slow and she needs me to “clean it up” for her, I never imagined the day she might be calling about the same problem with a medical device. While I’d obviously not have the same access to it that I have on a computer, it does reflect a scary situation in medical device technology today.
Dating and leak testing—how could these possibly be related? Whether you are single or married, you no doubt know someone or are someone who has tried to find a date in today’s world—on the Internet, in a bar, church social, or a favorite cousin’s dinner table.
The medical device industry is, without question, one of the most litigious industries. Medical device companies are constantly engaging in high-stakes patent or trade disputes, defending against product liability claimants, or fending off new market entrants. So when a seemingly harmless communication becomes a major piece of evidence in a case brought against your company, you do not want to be the one who hit “Send.”
60601 edition 3 is possibly the biggest change in the regulatory side of medical device development since the introduction of the FDA’s QSR. Until now, electrical safety testing was a black box test wherein a sample device was submitted and it passed or failed depending on a set of specific physical tests. There was no consideration of how the device was developed, just, “Is the device electrically safe?”
There are few industries as tightly interwoven with life and death issues as medical equipment. Getting everything right; from adherence to regulations to on-time product deliveries to perfectly performing products, is paramount. Complete transparency throughout the medical equipment supply chain is an absolute necessity. Transparency cannot be a part-time or partial commitment but rather, it must be an all-out endeavor to achieve safer and more effective patient healthcare.
In the time it takes to read this piece, 30 Chinese men and women will die from heart disease. This staggering statistic means that as Asia continues to witness astonishing growth and development, Asians will increasingly wrestle with the disease. Heart disease is already the number one killer in China and India, and is fast on the rise throughout Southeast Asia, where the World Health Organization reports that cardiovascular diseases accounts for 27% of all deaths.
Mary Poppins was wrong; it’s not a spoonful of sugar that helps the medicine go down, it’s a spoonful of “big data,” and it will make healthcare expenditure more palatable in the Doctor’s Office of 2050. As big data, telehealth, and the cloud come together, we will see healthcare reap the efficiency rewards of a decentralized approach.
The development of conformal coating technology was driven to a large degree by the military and aerospace industries. While conformal coatings are mostly used on populated, printed wiring boards (PWBs), they are also used to protect components such as transistors, diodes, rectifiers, resistors, integrated circuits (ICs), and hybrid circuits including multi-chip modules (MCMs) and chip on board (COB).
The migration of smart subsystems into products at every level of operation represents a true fusion of the electronic and mechanical, representing the next, and possibly the culmination of, the industrial revolution. However, the integration of sense, motion, and logic into all portions of a system also brings with it new (or old in new clothing) challenges in power management.
According to an article from Computer Weekly, mobility and accessibility are the driving factors behind the adoption of ruggedized tablets over computers on wheels (CoWs) in healthcare settings. As mentioned in a previous blog post, CoWs have several downsides...
I tried hard to find a topic other than the coming medical device excise tax to write about, however, either my brain didn’t have any more room to fit another topic or there’s just not that much else going on in the medical device industry (which is much less likely). I was also hesitant to write the column because, unlike with the web, there is a period of time that passes from the moment I complete the column until the time it is published and mailed where the content is out of my hands while outside forces can wreak havoc on the topic and the timing of its appearance.
I have yet to hop aboard the smart phone bandwagon. While I realize there are a number of benefits, to me, it still seems like a pricey way to access my e-mail and Facebook when I’m not home in front of my desktop computer. And really, I still don’t yet need that ability.
Design and manufacturing engineers strive to develop high-quality devices in a budget-conscious and timely manner. The problem is that a variety of challenges occur in the design and assembly processes that can present functionality issues of the finished device.
In 2011, the medical device market in the US was estimated to be $105.8 billion - a market based largely upon clinical and surgical interventions administered in hospitals. However, the design and manufacture of medical devices is undergoing paradigm shifts in cost and utility, motivated largely by miniaturization, which has revolutionized consumer products.
Every medical device manufacturer accepts that in the current regulatory environment, with the Food and Drug Administration (FDA) demanding complete life cycle traceability of every product, accurate labeling is a necessity. Yet the reality is far from satisfactory: many companies have issues with label quality, not knowing what was printed, discarding pre-printed stock and needing to dispose of labeled products; whilst product recalls and field instances are endemic not due to the failure of research and development or manufacturing processes but inaccurate labeling information.